AbbVie Korea said it obtained the Ministry of Food and Drug Safety’s approval for Venclexta (venetoclax) to treat chronic lymphocytic leukemia (CLL) on Wednesday. The treatment is the nation’s first and only oral B-cell lymphoma-2 (BCL-2) inhibitor.
The ministry granted the nod to the drug to be used as monotherapy for patients with relapsed CLL or those who are refractory to chemotherapy and BCL-2 inhibitor.
The phase-2 M14-032 study evaluated efficacy in patients with CLL with a history of ibrutinib or idelalisib treatment and whose disease progressed during or after the treatment. The results showed that the objective response rate of patients treated with Venclexta stood at 70 percent.
According to a recent study which analyzed the patient group by minimal residual disease (MRD), the median progression-free survival of patients without MRD was 24.7 months. MRD is an index to assess remission and recurrence after treatment by measuring the number of leukemic cells remaining in the peripheral blood or bone marrow.
Kim Jin-seok, a professor at the Hematology Department of Severance Hospital, said CLL patients had limited treatment options despite frequent relapses, even though CLL progresses slower than acute blood cancer. “The local approval for the new drug Venclexta opened the way for elderly patients and those with relapsed CLL to continue treatment. I hope this could prolong their lives and enhance the quality of life,” he said.
Venclexta was designated as an innovative medicine by the U.S. Food and Drug Administration in April 2016 and earned a license in 50 countries and regions including the U.S. and Europe. In Korea, the regulator designated Venclexta as an orphan drug in July 2018.
CLL is a blood cancer with an abnormal increase of lymphocytes in the blood. CLL is the most prevalent leukemia in the West, but it is rare in Korea. It accounts for only 0.4 to 0.5 percent of all leukemia in the nation. Significant symptoms include fatigue, weight loss, fever and night sweats. Most of them develop in people aged 60 or more.